Z-0432-2011

Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304

Name: Z-0432-2011 Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304
Creator: Philips Medical Systems
Published: 2008-08-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-08-07 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems began a recall of Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304 on 2008-08-07. The reason FDA records is "The affected device may not deliver appropriate defibrillation therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0432-2011
Status: Terminated
Initiated: 2008-08-07
Posted: 2010-11-22
Terminated: 2010-12-01
Recalling firm: Philips North America LLC
Product: Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The affected device may not deliver appropriate defibrillation therapy.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.
Quantity in commerce: 1 unit
Distribution: Nationwide Distribution: to one account in Arkansas.
Product codes and lots: Serial Number: B08G-01884

Product code MKJ

K050004Class IIIPhilips Heartstart Frx Defibrillator, Model 861304Philips Medical Systems / cleared 2005-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)